FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FALKON STRETCH
K Number: K854432
·
Decision Nov 22, 1985
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
5
Review Days
17
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Basic Information
- Device Name
- FALKON STRETCH
- K Number
- K854432
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- G.B.F. Industries, Inc.
- Date Received
- November 5, 1985
- Decision Date
- November 22, 1985
- Product Code
- EFQ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
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